Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nemvaleukin Alfa · 2 trials · 2 indications
ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
| Arm | Type | Description |
|---|---|---|
| Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with current stable disease (SD) or partial response (PR) (Cohorts 1 and 2) who were not progressing or further demonstrating reductions in tumor size were to receive nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| Group 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with progressive disease (PD) (Cohorts 3 and 4) received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and Pembrolizumab | EXPERIMENTAL | Nemvaleukin will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of nemvaleukin |
| Cohort 2 Part A: Less Frequent IV Dosing Nemvaleukin | EXPERIMENTAL | - |
| Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and Pembrolizumab | EXPERIMENTAL | This arm will not open for enrollment. |
| Name | Type | Description |
|---|---|---|
| Nemvaleukin Alfa | DRUG | Nemvaleukin alfa IV infusion. |
| Pembrolizumab | DRUG | Pembrolizumab IV infusion. |
Inclusion Criteria: * Patients must have histologically or cytopathologically confirmed diagnosis of non-cutaneous squamous cell carcinoma of the head and neck region that is locally advanced and/or recurrent and no longer amenable to local surgical or radiation therapy and/or with evidence of dist...